Impact of FDA black box warning on fluoroquinolone and alternative antibiotic use in southeastern US hospitals

Abstract

We analyzed antibiotic use data from 29 southeastern US hospitals over a 5-year period to determine changes in antibiotic use after the fluoroquinolone US Food and Drug Administration (FDA) advisory update in 2016. Fluoroquinolone use declined both before and after the FDA announcement, and the use of select, alternative antibiotics increased after the announcement. Fluoroquinolones are among the 4 most commonly prescribed antibiotic classes. 1,2 Postmarketing reports of serious adverse events linked to fluoroquinolones include tendonitis, neuropathy, hypoglycemia, psychiatric side effects, and possible aortic vessel rupture, leading to safety label changes in , the US Food and Drug Administration (FDA) strengthened the "black box" warning following an initial safety announcement in May 2016, recommending avoidance of fluoroquinolones for uncomplicated infections such as acute exacerbation of chronic bronchitis, uncomplicated urinary tract infections, and acute bacterial sinusitis. 4 Concerns over safety and the association with Clostridiodes difficile infection have led inpatient antimicrobial stewardship programs (ASPs) to develop initiatives to promote avoidance of quinolones. The objective of this study was to quantify the effect of the 2016 FDA "black box" update on inpatient antibiotic use among a cohort of southeastern US hospitals.

Role of antimicrobial restrictions in bacterial resistance control: a systematic literature review

“…Finally, it is unclear whether fluoroquinolones could be a preferred substitute choice given that the available information is scarce and poorly informative [10,12]. Furthermore, current recommendations warn against their widespread use for safety concerns; an issue which was not examined by the authors [15].…”

VNRX-5133 (Taniborbactam), a Broad-Spectrum Inhibitor of Serine- and Metallo-β-Lactamases, Restores Activity of Cefepime in Enterobacterales and Pseudomonas aeruginosa

“…No new antibiotic classes, particularly those active against the challenging Gram-negative pathogens, have been introduced since the introduction of the fluoroquinolones. At the same time, serious resistance and safety concerns over several commonly used classes, including the fluoroquinolones (7)(8)(9) and polymyxins (10)(11), have severely narrowed safe and effective options for the treatment of these life-threatening infections (4).…”

A qualitative analysis of diagnostic testing, antibiotic selection, and quality improvement interventions for uncomplicated urinary tract infections

“…The FDA specifically recommends not using this class for uncomplicated UTIs [22]. One study showed no change in fluoroquinolone prescribing for outpatient uncomplicated UTIs following the 2016 boxed warning [24], however another study demonstrated a decreased number of fluoroquinolone prescriptions in the inpatient setting for all infections [25]. In our qualitative analysis, residents and community providers seemed to be aware of these warnings, however they did not appear to have a major influence on prescribing patterns.…”